Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Objective:
Assists with coordinating quality activities of a designated Customer Focused Team to ensure that the goals and objectives of the team are accomplished within prescribed time frames and within budget. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management. Updates Batch Record Documentation and Material Specifications to ensure compliance standards are met and maintained. Facilitates customer questions for Batch Record review and Documentation Updates. Maintains a positive working relationship with internal and external customers.
1. Primary reviewer for master batch records, forms, and specifications to ensure that the documents meet internal and customer requirements for standards, procedures, and requirements.
2. Assist with creating and updating batch records, forms, and material specifications as well as organizing internal and customer approval of batch records and specifications.
3. Assist with performing record reviews of completed orders and orders in process to ensure compliance with cGMP’s and customer requirements. Assist as company liaison with customers concerning quality control documentation. Help identify, communicate, track, and resolve document-related issues with other departments and customers.
4. Performs finished product batch release of approved production lots.
5. Attend conference calls and customer meetings; provide complaint and quality-related information.
6. Assist in the preparation of annual product review data.
7. Assist with generating and presenting quality-related metrics and key performance indicators for the team’s performance.
8. Assist with the investigation of Quality deviations and the drafting of investigation reports associated with such deviations.
9. Assist with addressing and documenting quality events with Production and Quality teams.
10. Assist with training, developing, and mentoring new Quality Coordinators.
11. This position may require overtime and/or weekend work.
12. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
13. Attendance to work is an essential function of this position
14. Performs other duties as assigned by Manager/Supervisor.
15. Develop, update, and implement procedural changes throughout the organization.
16. Standardize documentation to ensure PCI’s Standard for Quality is achieved throughout our customer base.
17. Coach, train, mentor, and develop PCI’s employees to ensure Quality Standards are met and maintained.
18. Schedule, host, and lead meetings to develop, implement and/or update Batch Records, Material Specifications, Forms, Work Practices, and Standard Operating Procedures.
19. Assist with In-Process / Finished Goods Inspections, Annual Retain Inspections, Customer Complaint Samples, or Rework as needed to support the various groups throughout PCI.
20. Compile, update, and analyze customer / internal data and metrics to identify potential trends and areas for opportunities. Utilize the Microsoft Office Suite in detail to present data/facts in a professional fashion.
21. Assist and Support the RIT Investigation process through online interactions with the Operations staff. Provide a summary of the findings/investigation to the appropriate Business Unit representative.
22. Present data to customers / internal management with ease and without undue hardship.
23 . Maintain positive external and internal customer relationships with face-to-face, email, and voice communication. Provide the appropriate feedback within 24 hours of notification.
24. Assist with Supplier Investigations as needed.
25. Assess and provide detailed reports/summaries on the impact of process changes on PCI management.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Required:
- Associate's Degree in a related field and/or 1-3 years related experience and/or training.
- College Level Mathematical Skills
- Intermediate Computer Skills: Ability to perform more complex computer tasks and knows various computer programs.
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
- High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in
situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
Preferred
- Ability to demonstrate attention to detail.
- Ability to work independently and/or as part of a team.
- Ability to hold oneself in a professional manner.
- Ability to effectively present information to various people as the job requires.
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
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